510(k) K061019
- Device
- TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS
- Applicant
- SMITH & NEPHEW, INC.
- 510(k) number
- K061019
- Product code
- JDS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-06
- Date received
- 2006-04-13
- Regulation
- 888.3030
- Classification name
- Nail, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID HENLEY
- Address
- 1450 Brooks Rd. Memphis TN US 38116 38116
FDA Registration Numbers#
- 3015869492
- 3030714745
- 3006128100
- 2029275
- 2183449
- 3010041499
- 9615021
- 3014527928
- 3021008900
- 3006513362
- 9611813
- 3033509898
- 3010303097
- 3005874553
- 9613910
- 3002907620
- 3009973505
- 3010863450
- 1043653
- 3008868758
- 3010363503
- 8043792
- 3010220595
- 3015183635
- 3003761012
- 3008812560
- 3009882675
- 3006783837
- 3015869493
- 9616944
- 3007766601
- 3017528621
- 3000270450
- 2522206
- 3009417901
- 3015440604
- 1020279
- 3003541440
- 1825034
- 1064129
- 1643817
- 1828288
- 1822565
- 3016438694
- 1061124
- 1526534
- 3004358587
- 3025603301
- 3010120104
- 3007420745
- 3015876273
- 3015207155
- 3006694268
- 3010049501
- 2249615
- 3013302242
- 2031009
- 1834331
- 3004638532
- 3009217531
- 3008534770
- 3008744062
- 3014976005
- 3010041430
- 3008791302
- 3015212339
- 3013176080
- 1643264
- 3011500362
- 3007923096
- 3035366890
- 9611390
- 3004369035
- 3015946784
- 3030412764
- 3007593722
- 1833920
- 3014170143
- 1720929
Source Documents#
Other 510(k) Records For Product Code JDS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243608 | TRIGEN Stable Lock Nut & Washer | Smith & Nephew, Inc. | 2025-06-12 |
| K240061 | TRIGEN MAX Tibial Nail System; INTERTAN MAX Hip Fracture Nail System | Smith & Nephew, Inc. | 2024-09-20 |
| K241804 | TRIGEN INTERTAN 10S Nail System | Smith & Nephew, Inc. | 2024-08-22 |
| K233150 | NET BRAND Osteosynthesis Nailing System | Narang Medical , Ltd. | 2024-02-20 |
| K230761 | TRIGEN META-NAIL Nail System | Smith & Nephew, Inc. | 2023-06-14 |
| K201336 | DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm | Synthes (USA) Products, LLC | 2020-09-03 |
| K192003 | Auxein Nailing System | Auxein Medical Private Limited | 2020-06-10 |
| K193533 | WIN Flexible Nail System | Biomet, Inc. | 2020-02-20 |
| K141737 | CONVENTUS PHS SYSTEM | Conventus Orthopaedics, Inc. | 2015-04-08 |
| K123948 | CHINA NAILS AND ACCESSORIES | Smith & Nephew, Inc. | 2013-03-14 |
| K111667 | SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS | Synthes (Usa) | 2011-12-05 |
| K080706 | CONNEXX LOCKING TIBIA NAIL | I.T.S. Implantat-Technologie-Systeme GmbH | 2008-06-09 |
| K072095 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS | Synthes (Usa) | 2007-09-27 |
| K062872 | SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM | Synthes (Usa) | 2007-03-13 |
| K061783 | KNEE FUSION NAIL | Smith & Nephew, Inc. | 2006-08-10 |
Legacy Summary#
summary
FDA Review#
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